7 effortless rules to follow during an FDA Inspection

Author: Marie Dorat
The US Food and Drug Administration inspect processors and manufacturers of FDA-regulated goods to confirm that they comply with pertinent regulations. FDA conducts various types of inspections to protect consumers from harmful products. The three types of inspections are
  • Pre-approval inspection which is done after an organization submits an application to Food and Drug Administration to market a new product.
  • Routine inspection is done on a regulated facility.
  • "For-cause" inspection to examine a definite problem that has caused the FDA’s attention.
Here are seven simple rules to follow during an FDA inspection inorder to gain a positive feedback.
1. Do not get nervous
An FDA inspection could be stressful. So before facing an inspector an employee must follow certain dos and don’ts for the smooth running of an inspection. Be courteous and responsive. Be professional and show courtesy to every visitor. Answer to the point and do not panic.
2. Be a good listener
Listen to all questions carefully. Never just on to an answer without hearing the question fully. If you require more clarity on the question asked by the inspector, ask him to repeat.
3. No guessing please
If you are unsure of the answer to certain question, do not guess and give a blunt reply. The best way is to ask the inspector to pardon yourself and call up the right person, who can more appropriately respond to the question.
4. Do not be confrontational
While responding to an inspector’s query, the employee needs to keep a level head. If you feel the questions to be threatening or accusatory, attempt to reword it. For instance, an inspector may ask, “Why did you put in writing this SOP?” Twist that question around and solicit, “So, you want to discover why the company’s policies state that this SOP be printed like this?” Twisting the question to reproduce a neutral perspective can often lessen tension and aid to return focus to the issue. Glue to the facts, and never give a chance for emotional foul play as the can give rise to negative results.
5. Do not try to play games with inspectors
There are times when the staff on not knowing the answer tries to play games with the inspector by trying to confuse them with irrelevant information. Inspectors turn suspicious about staff members, who try to mislead them, and they might get the notion that the company is trying to hide something. During situations like this, it is good to respond by saying, “I will get back to you on that or I require more time to go through the details.”
6. Respond swiftly and precisely
Inspectors keep a track of what they ask for, the efficacy of the inspection reporter and of the war room persons can make sure that order is brought to the inspection. A fast and precise response to an inspector’s query can leave a positive impression. Have validation procedures, batch records, reports, SOPs, and other documents available. Provide special attention to documentation relating to divergences, changes, failed tests, and to decision-making procedures (such as R&D reports and memos).
7. Provide documentation
The inspectors must be supplied with all the documents they have asked for. On a war-footing review every document to guarantee that the information is precise and complete. Also, get rid of any unwanted items like extra pages or hand-written comments from the documents presented to the inspector. Always keep an extra copy of the document sets that you give to the inspector with the organization, so that it serve as a future reference to what all document are being provided.

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